NeuroendocrinologyNCT04848948
Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health
A study testing Calory Restriction (F.X. Mayr & VLCD) and Biofeedback in people with Neuroendocrinology and Mental Stress, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Backgroup/relevance: Overweight and obesity, defined by a respective body mass index of above 25 and 30 kg/m2, are getting increasingly common in all regions of the world. Obesity is currently estimated to be present in more than 10% of the global population while overweight roughly reached an estimate of 40% in 2016. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrinology, Mental Stress, Psychological
- What is being tested?
- Calory Restriction (F.X. Mayr & VLCD) and Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2019to 4 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women willing to undergo two-weeks of calory restriction
- at least 18 years of age
Who cannot join
- currently pregnant
- any acute or a severe chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Short-term Calory Restriction and Biofeedback on Anthropometric and Metabolic Parameters as Well as Biological and Psychological Stress Correlates in Healthy Women
Backgroup/relevance: Overweight and obesity, defined by a respective body mass index of above 25 and 30 kg/m2, are getting increasingly common in all regions of the world. Obesity is currently estimated to be present in more than 10% of the global population while overweight roughly reached an estimate of 40% in 2016.
Overweight dramatically increases the risk for a wide range of disorders such as diabetes mellitus and other metabolic and cardiovascular disorders subsumed under the term metabolic syndrome, increasing the risk for life-threatening cardiovascular events such as myocardial infarction and stroke. Similar to other chronic diseases such as mental health disorders, prescribing medication was oftentimes insufficient and should be complemented by patient empowerment to reach sufficient treatment adherence and control of lifestyle factors. Thereby, overweight and obesity can easily be challenged by patients themselves without pharmacological intervention.
Read more
Overweight may place central in the crossroad between metabolic and mental health for several reasons. Excessive body fat is known to cause subclinical inflammation that was also associated with many psychiatric disorders such as major depression. Similarly, the hypothalamic-pituitary-adrenal axis relevant for stress response was shown to be dysregulated in both metabolic and mental health disorders.
Study design: In this study, non-pharmacological interventions are applied in healthy women with overweight or obesity and self-perceived psychological stress. Women staying at the "la pura" women´s health resort (www.lapura.at/) are invited to partake in the study and receive a short-term intervention of calory restriction. Thereby, either F.X. Mayr or very-low-calory-diet (VLCD) will be applied, reducing calory intake to 700-800 kcal/die. Following random assigment to four treatment arms, half of the women also receive a 7-session clinical-psychological intervention consisting of biofeedback, individualized psycho-education on stress prevention and mindlessness training.
Women are assessed at baseline and after two weeks of interventions for metabolic parameters such as insulin functioning, anthropometric parameters such as body weight and body fat, blood parameters such as sex hormones, fat metabolism and liver function, parameters of neuroplasticity such as brain derived neurotrophic factor (BDNF), as well as psychological and biological stress correlates and mental health symptom dimensions.
- Conditions
- Neuroendocrinology, Mental Stress, Psychological, Obesity
- Being tested
- Calory Restriction (F.X. Mayr & VLCD), Biofeedback
- Medical subject headings
- Stress, Psychological, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calory Restriction (F.X. Mayr & VLCD)Behavioural
VLCD restricts calory intake to 630 - 700 kcal per day (20% fat, 34% protein, 46% carbohydrates).
F.X. Mayr diet similarly applies calorie restriction to 700 - 800 kcal per day and includes daily ingestion of isotonic magnesium sulfate solution.
BiofeedbackBehavioural
Three sessions of biofeedback (50 minutes) over a time frame of 14 days, aimed at improving biological functions and especially heart-rate-variability under stress condition.
| Study group | Role | What they receive |
|---|---|---|
| F.X.Mayr & Biofeedback | Experimental | two weeks of F.X. Mayr diet and biofeedback Receives: Behavioral: Calory Restriction (F.X. Mayr & VLCD); Behavioral: Biofeedback |
| F.X.Mayr | Active comparator | two weeks of F.X. Mayr diet Receives: Behavioral: Calory Restriction (F.X. Mayr & VLCD) |
| VLCD & Biofeedback | Experimental | two weeks of very low calorie diet and biofeedback Receives: Behavioral: Calory Restriction (F.X. Mayr & VLCD); Behavioral: Biofeedback |
| VLCD | Active comparator | two weeks of very low calorie diet Receives: Behavioral: Calory Restriction (F.X. Mayr & VLCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSS score
Perceived Stress Scale total score
Measured: Baseline, changes over two weeks
BODI
buron-out-diagnostic-inventory scores, 4 summary items and 3 stress self-ratings
Measured: Baseline, changes over two weeks
BSI
Brief Symptom Inventory, 9 dimensional subscores and global severity score
Measured: Baseline, changes over two weeks
waist-to-height ratio
Anthropometric parameter
Measured: Baseline
HbA1c
Glycated hemoglobin
Measured: Baseline
HOMA-IR
Functional parameter for insulin resistance
Measured: Baseline
Matsuda Index
Functional parameter for insulin sensitivity
Measured: Baseline
Body mass index
weight in relation to height
Measured: Baseline, changes over two weeks
HRV
heart rate variability
Measured: Baseline, changes over two weeks
Secondary outcomes (15)
Body fat
measured by bioimpedance analysis
Measured: Baseline, changes over two weeks
lean mass
measured by bioimpedance analysis
Measured: Baseline, changes over two weeks
Phase angle
ratio of reactance versus electric resistance, measured by bioimpedance analysis
Measured: Baseline, changes over two weeks
Resistin
Adipocines
Measured: Baseline, changes over two weeks
Leptin
Adipocines
Measured: Baseline, changes over two weeks
Secretagogin
Adipocines
Measured: Baseline, changes over two weeks
Adiponectin
Adipocines
Measured: Baseline, changes over two weeks
BDNF
brain derived neurotrophic factor
Measured: Baseline, changes over two weeks
Estrogen
Sex hormone
Measured: Baseline, changes over two weeks
Testosterone
Sex hormone
Measured: Baseline, changes over two weeks
Luteinizing hormone
Sex hormone
Measured: Baseline, changes over two weeks
Follicle-stimulating hormone
Sex hormone
Measured: Baseline, changes over two weeks
Total cholesterol
Lipid metabolism
Measured: Baseline, changes over two weeks
High-density lipoprotein (HDL)
Lipid metabolism
Measured: Baseline, changes over two weeks
BSRI
Bem sex role inventory, female, male, neutral scores
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Sep 2019
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroendocrinologyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Kautzky-Willer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848948
- Sponsor's protocol ID
- 2020-GI-01
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term Calory Restriction and Biofeedback on Anthropometric and Metabolic Parameters as Well as Biological and Psychological Stress Correlates in Healthy Women
- ClinicalTrials.gov ID
- NCT04848948
- Acronym / sponsor ID
- 2020-GI-01
- Conditions
- Neuroendocrinology, Mental Stress, Psychological, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Backgroup/relevance: Overweight and obesity, defined by a respective body mass index of above 25 and 30 kg/m2, are getting increasingly common in all regions of the world. Obesity is currently estimated to be present in more than 10% of the global population while overweight roughly reached an estimate of 40% in 2016.
Overweight dramatically increases the risk for a wide range of disorders such as diabetes mellitus and other metabolic and cardiovascular disorders subsumed under the term metabolic syndrome, increasing the risk for life-threatening cardiovascular events such as myocardial infarction and stroke. Similar to other chronic diseases such as mental health disorders, prescribing medication was oftentimes insufficient and should be complemented by patient empowerment to reach sufficient treatment adherence and control of lifestyle factors. Thereby, overweight and obesity can easily be challenged by patients themselves without pharmacological intervention.
Overweight may place central in the crossroad between metabolic and mental health for several reasons. Excessive body fat is known to cause subclinical inflammation that was also associated with many psychiatric disorders such as major depression. Similarly, the hypothalamic-pituitary-adrenal axis relevant for stress response was shown to be dysregulated in both metabolic and mental health disorders.
Study design: In this study, non-pharmacological interventions are applied in healthy women with overweight or obesity and self-perceived psychological stress. Women staying at the "la pura" women´s health resort (www.lapura.at/) are invited to partake in the study and receive a short-term intervention of calory restriction. Thereby, either F.X. Mayr or very-low-calory-diet (VLCD) will be applied, reducing calory intake to 700-800 kcal/die. Following random assigment to four treatment arms, half of the women also receive a 7-session clinical-psychological intervention consisting of biofeedback, individualized psycho-education on stress prevention and mindlessness training.
Women are assessed at baseline and after two weeks of interventions for metabolic parameters such as insulin functioning, anthropometric parameters such as body weight and body fat, blood parameters such as sex hormones, fat metabolism and liver function, parameters of neuroplasticity such as brain derived neurotrophic factor (BDNF), as well as psychological and biological stress correlates and mental health symptom dimensions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| F.X.Mayr & Biofeedback | Experimental | Behavioral: Calory Restriction (F.X. Mayr & VLCD), Behavioral: Biofeedbacktwo weeks of F.X. Mayr diet and biofeedback |
| F.X.Mayr | Active comparator | Behavioral: Calory Restriction (F.X. Mayr & VLCD)two weeks of F.X. Mayr diet |
| VLCD & Biofeedback | Experimental | Behavioral: Calory Restriction (F.X. Mayr & VLCD), Behavioral: Biofeedbacktwo weeks of very low calorie diet and biofeedback |
| VLCD | Active comparator | Behavioral: Calory Restriction (F.X. Mayr & VLCD)two weeks of very low calorie diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women willing to undergo two-weeks of calory restriction
- at least 18 years of age
Key exclusion criteria (2 listed)
- currently pregnant
- any acute or a severe chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calory Restriction (F.X. Mayr & VLCD)VLCD restricts calory intake to 630 - 700 kcal per day (20% fat, 34% protein, 46% carbohydrates). F.X. Mayr diet similarly applies calorie restriction to 700 - 800 kcal per day and includes daily ingestion of isotonic magnesium sulfate solution. | Behavioural | F.X.Mayr, F.X.Mayr & Biofeedback, VLCD, VLCD & Biofeedback |
| BiofeedbackThree sessions of biofeedback (50 minutes) over a time frame of 14 days, aimed at improving biological functions and especially heart-rate-variability under stress condition. | Behavioural | F.X.Mayr & Biofeedback, VLCD & Biofeedback |
Primary outcome
PSS score
Time frame: Baseline, changes over two weeks
Perceived Stress Scale total score
BODI
Time frame: Baseline, changes over two weeks
buron-out-diagnostic-inventory scores, 4 summary items and 3 stress self-ratings
BSI
Time frame: Baseline, changes over two weeks
Brief Symptom Inventory, 9 dimensional subscores and global severity score
waist-to-height ratio
Time frame: Baseline
Anthropometric parameter
HbA1c
Time frame: Baseline
Glycated hemoglobin
HOMA-IR
Time frame: Baseline
Functional parameter for insulin resistance
Matsuda Index
Time frame: Baseline
Functional parameter for insulin sensitivity
Body mass index
Time frame: Baseline, changes over two weeks
weight in relation to height
HRV
Time frame: Baseline, changes over two weeks
heart rate variability
15 secondary outcomes
Body fat
Time frame: Baseline, changes over two weeks
lean mass
Time frame: Baseline, changes over two weeks
Phase angle
Time frame: Baseline, changes over two weeks
Resistin
Time frame: Baseline, changes over two weeks
Leptin
Time frame: Baseline, changes over two weeks
Secretagogin
Time frame: Baseline, changes over two weeks
Adiponectin
Time frame: Baseline, changes over two weeks
BDNF
Time frame: Baseline, changes over two weeks
Estrogen
Time frame: Baseline, changes over two weeks
Testosterone
Time frame: Baseline, changes over two weeks
Luteinizing hormone
Time frame: Baseline, changes over two weeks
Follicle-stimulating hormone
Time frame: Baseline, changes over two weeks
Total cholesterol
Time frame: Baseline, changes over two weeks
High-density lipoprotein (HDL)
Time frame: Baseline, changes over two weeks
BSRI
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: Undecided. Upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calory Restriction (F.X. Mayr & VLCD) and Biofeedback in people with Neuroendocrinology and Mental Stress, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSS score (time frame: Baseline, changes over two weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.